Wednesday March 17, 2021 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals (NYSE American: AMPE) revealed preliminary positive results in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19.
The company also outlined its progress toward initiating a Phase I clinical trial using inhaled Ampion for treating those suffering lingering respiratory effects after COVID-19 infection, the so-called COVID-19 "long haulers," as well as its continued research focusing on the use of Ampion in kidney and pediatric diseases.
"We shared these promising results with the FDA in our recent request to expand that trial,” said Michael Macaluso, chair and CEO of Ampio Pharmaceuticals.
“The FDA's response recommended that we forego our planned unblinded expansion of the current trial and move directly to a randomized, double-blinded, placebo-controlled Phase II study of inhaled Ampion in COVID-19.
"It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy."
Preliminary results from the AP-014 Phase I trial of inhaled Ampion indicate:
- Ampion demonstrated an improvement in all-cause mortality in COVID-19 patients compared to standard of care (SOC). A lower all-cause mortality rate of 8% is observed for the Ampion treatment group, compared to 21% in standard of care alone.
- Patients who received Ampion required less hospitalization time. The average hospital length of stay was 7 days for the Ampion group compared to 11 days for standard of care patients.
- Patients who received Ampion required less oxygen than standard of care alone, and 86% of Ampion patients were stable or had improvement compared to 75% of SOC patients.
- More patients who received Ampion were stable or had improvement on a scale of clinical improvement compared to standard of care alone. By day 5, 86% of patients who received Ampion were stable or had improvement compared to 75% of standard of care patients. This trend in improvement with Ampion treatment is noted as early as day 2 and continues to day 5.
- Adverse events were the same between Ampion and standard of care, and no drug-related serious adverse events have been reported.
"The scientific findings we have reviewed thus far are fascinating and very encouraging,” said Dr. David Cornutt, chair, Department of Emergency Medicine, Regional West Health Services and a medical monitor on the study.
“While we are still looking at preliminary data from a small sample size, the safety signals look strong, and I look forward to moving into the efficacy phases to come."
Ampio also provided details on its forthcoming Phase I clinical trial utilizing inhaled Ampion with patients exhibiting "long hauler" COVID-19 symptoms, now known clinically as Post-Acute Sequelae of SARS-CoV-2, or PASC.
A significant percentage of the millions of people who have contracted COVID-19 over the past year -- even those with mild or asymptomatic cases -- continue to suffer effects from the disease long after there is no detectable virus in their system.
"The complications from COVID-19 stem not from the virus but from the out-of-control inflammatory immune response it triggers, which remains a problem long after the infection is over.
“We believe that inhaled Ampion could provide a significant therapeutic benefit for those patients plagued by PASC ("long haul symptoms").
"And, because Ampion is a platform biologic, what we learn in our upcoming trial could be applicable to a significant number of diseases displaying similar inflammatory-type characteristics, not just COVID-19."
The trial design will deal specifically with respiratory distress-related symptoms and will involve an "at home" treatment, where patients will receive a nebulizer and a five-day supply of inhaled Ampion.
The trial protocol is currently being finalized, with commencement of the study expected by mid-Q2 2021.
In collaboration with physician scientists at Vanderbilt University, Ampio is studying the effects of Ampion on inflammation in kidney function, as most kidney disorders involve inflammation.
The preclinical research is being done in vitro on renal endothelial cells as well as on proximal tubular epithelial cells of the kidney, all cells involved in the pathophysiology of kidney inflammation.
"The results so far are promising as Ampion's method of action aligns both theoretically and is confirmed by initial in vitro experiments on those cells,” said David Bar-Or, Ampio director and founder.
Ampio is also conducting research into the potential use of Ampion in treating post-Fontan protein-losing enteropathy in conjunction with clinicians and scientists at a major children's hospital based in Philadelphia.
The Fontan procedure is a cardiac surgery performed on children born with a single chamber in their heart. Essentially, the procedure involves separating the venous from the arterial blood. Some of these children develop a post-procedure condition termed protein-losing enteropathy, which can be so severe that it necessitates a heart transplant.
"The cause of this condition is unclear and involves several theories," said Bar-Or. "One theory involves inflammation, and we are studying this angle by performing complex in silico work on available genomics, micro-RNA, and other data sets to determine the potential molecular pathways involved.
“We are also undertaking in vitro experiments on lymphatic endothelial cells permeability, intestinal epithelial cells and others to demonstrate the potential beneficial effect of Ampion in this condition. This may lead to a treatment option for this dreadful condition affecting young children."